Device Classification Name |
Instrument, Ultrasonic Surgical
|
510(k) Number |
K063192 |
Device Name |
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
ELIZABETH MILLER, MST |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
ELIZABETH MILLER, MST |
Classification Product Code |
|
Date Received | 10/20/2006 |
Decision Date | 01/30/2007 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|